Oral Nicotine Products for Nicotine Addiction
Trial Summary
What is the purpose of this trial?
There has been a recent proliferation of novel oral nicotine products (ONPs) brought to market, including new nicotine gums and pouches. Unlike electronic cigarettes (ECs) ONPs have no impending regulatory barriers with regard to flavoring or nicotine dose, and manufacturers have capitalized on this by introducing an extensive slate of characterizing flavors and nicotine concentrations. Both sales trajectory and the surge in marketing suggest ONP use is likely to increase in the coming years. Work by the investigators and others indicates that interest in these products is high among current EC users, and among specific demographic groups including those who identify as sexual and gender minority (SGM). ONP use is discrete and so can function as a secondary source of nicotine, encouraging dual use patterns and more severe nicotine dependence. Depending on the use patterns of ONPs that emerge, regulation of ONPs may serve the public health interest. However, very little is known about factors relevant to the actual appeal and abuse liability of these products. The investigators propose to address this important gap by assessing the appeal and abuse liability of gum and pouch ONPs as a function of flavor (mint vs fruit) and nicotine concentration (2mg vs. 4mg). Flavor and nicotine strength, along with product type, are regulatable attributes, and so it is essential to understand their impact on appeal and abuse liability. Evidence from EC use suggests a potential interaction between flavor and nicotine strength, with flavorants in the "mint" category desensitizing receptors integral to the aversive sensory experience of nicotine, leading to greater tolerability of high nicotine concentration. Because of current ONP marketing emphasis on youth, the investigators will recruit young adult exclusive EC users (N = 320; ages 21 - 25). The investigators will target recruitment of a sufficient number of SGM participants (N = 64, 20% of sample) to allow assessment of potential differentiation of this group. Participants will complete one virtual session focused on assessment of the sensory appeal of ONPs. Based on individual participant ratings, the preferred fruit and the preferred mint ONP will be selected (from their randomized product type and nicotine strength) to each be assessed in a single-product session examining factors known to predict abuse liability (relief of withdrawal, liking, behavioral economic indices of demand, and follow-up naturalistic product use). The investigators will pay particular attention to evidence suggesting dual use potential of ONPs, given its association with greater severity of nicotine dependence. The proposed work will inform efforts to mitigate ONPs potential to promote dual-use and more severe nicotine dependence among young adult EC users, by isolating the impact of potential regulatory targets.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you are not using any other tobacco or nicotine products besides electronic cigarettes.
What data supports the idea that Oral Nicotine Products for Nicotine Addiction is an effective treatment?
The available research shows that oral nicotine products like Zonnic pouches can help reduce withdrawal symptoms and increase user satisfaction compared to a placebo. In a study, Zonnic pouches were compared to nicotine gum and a placebo, and they were found to be effective in relieving withdrawal discomfort after not smoking overnight. This suggests that oral nicotine products can be a helpful treatment for nicotine addiction. Additionally, these products may be more acceptable to users, which is important for their success as a treatment.12345
What safety data exists for oral nicotine products?
Existing safety data for oral nicotine products, such as nicotine pouches, gums, and lozenges, indicate that they may serve as a lower-risk alternative to traditional tobacco products like cigarettes and smokeless tobacco. Studies have shown that users of products like ZYN and Velo have significantly lower exposure to harmful tobacco toxicants compared to smokers. Biomarkers of potential harm and exposure are more favorable in users of these products, suggesting a reduced risk of smoking-related diseases. However, the long-term public health impact of these products is still unknown.26789
Research Team
John R Monterosso, PhD
Principal Investigator
University of Southern California
Eligibility Criteria
This trial is for young adult electronic cigarette users aged 21-25, with a focus on including sexual and gender minority participants. It's designed to understand how flavor (mint vs fruit) and nicotine strength (2mg vs 4mg) in oral nicotine products affect their appeal and potential for abuse.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Orientation
Participants complete an orientation session to provide informed consent and confirm eligibility
Sensory Appeal Session
Participants rate the appeal and sensory attributes of different ONPs after self-administration
Abuse Liability Sessions
Participants undergo two sessions to assess abuse liability of ONPs, including self-administration and monitoring
Follow-up
Participants are monitored for naturalistic use of ONPs and dual use liability
Treatment Details
Interventions
- Oral Nicotine Products
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Food and Drug Administration (FDA)
Collaborator
National Cancer Institute (NCI)
Collaborator